1Other quality system
The recorded information or details were inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
Inspection Record
Ranbaxy Pharmaceuticals Canada Inc. (a SUN PHARMA Company) — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
3Complaint and recall handling
The company's oversight of the contracted party was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Other quality system
Measures to ensure the compliance of the contracted test laboratories were inadequate.
6Other quality system
The implementation of a self-inspection program was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-01. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
